CompletedNot Applicable

WISE Cortical Strip for Intraoperative Neurophysiological Monitoring

Germany, Italy, Switzerland32 participantsStarted 2019-04-09

Plain-language summary

The WIN Study is a prospective, interventional, multi-center, open-label premarket study designed to confirm the safety, performance and intended use of the WISE Cortical Strip (WCS) for CE certification purposes. Participants with documented diagnosis of epilepsy or brain tumor requiring intracranial surgery, who meet all eligibility criteria, will undergo IntraOperative Neurophysiological Monitoring (IONM) during a neurosurgical intervention with the WCS and a comparator device.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Brain tumor or epilepsy that require neurosurgical intervention and exposure of the central region of the cerebral cortex including at least the hand-forearm areas in the primary motor cortex and the primary somatosensory cortex (i.e. excision of lesion, open approach)
✓. Age: 18 - 75 years at the time of enrollment
✓. Required intraoperative neurophysiological monitoring with subdural electrodes
✓. Willingness to provide informed consent for participating in the study

Exclusion criteria

✕. Significant psychiatric impairments which, in the opinion of the investigator, will interfere with the proper administration or completion of the protocol
✕. Acute or untreated infections (viral, bacterial or fungal)
✕. Currently on any anticoagulant medication that cannot be discontinued during the perioperative period, or patients with factor XIII deficiency or any other hematological disease
✕. Current treatment with antibiotics

What they're measuring

Serious Adverse Device Effects (SADEs) of the WISE Cortical Strip.

Timeframe: For the entire duration of the surgeries and after 24 hours

The Signal-to-Noise Ratio percentage (SNR%) calculated on Somatosensory Evoked Potential (SEP) signals.

Timeframe: During the surgery

Trial details

NCT IDNCT03731455

SponsorWise S.r.l.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-01-20

View on ClinicalTrials.gov More Brain Tumor Adult trials